A 164-gene pan-tumor CGP panel deployed in-house at our Kassel, Germany facility under Health Institution status. Results in 7 to 10 days.
Pan-tumor comprehensive panel covering actionable oncogenes, emerging TKI targets, and DNA damage repair pathways, in a single test run.
Fast turnaround at our Kassel, Germany facility to rapidly identify and enroll patients. No third-party handoffs. No cross-border delays.
Deployed as an in-house device under Health Institution status. Prospective clinical use ready, without the performance study delays of standard IVDR pathways.
LuminosĀ® is Discovery Life Sciencesā comprehensive genomic profiling platform, developed to meet the specific demands of oncology clinical trials. Built on validated, IVDR-compliant laboratory-developed tests and deployed in-house at our Kassel, Germany facility, LuminosĀ® brings together panel breadth, operational speed, and regulatory confidence in a single integrated offering.
LuminosĀ® Comprehensive is the platformās foundational tissue-based panel, a 164-gene, pan-tumor assay covering actionable oncogenes, emerging therapeutic targets, and DNA damage repair / synthetic lethal pathways. From enrollment screening to companion diagnostic support, it delivers the full genomic picture trial teams need, without the logistical and regulatory overhead of third-party reference laboratories.
LuminosĀ® Liquid, incorporating DNA and RNA inputs for liquid biopsy applications, is scheduled to launch in Fall 2026, expanding the platformās specimen coverage for studies requiring serial monitoring or tissue-inaccessible cases.
| Specification | Detail |
|---|---|
| Panel type | Pan-tumor comprehensive genomic profiling |
| Number of genes | 164 |
| Specimen type | FFPE tissue – block preferred; slides accepted (fresh cut preferred) |
| Variant types detected | SNVs, indels |
| Turnaround time | 7ā10 business days |
| Regulatory status | IVDR-compliant laboratory-developed test (LDT) |
| Deployment | In-house, Kassel, Germany |
| Health Institution status | Yes, recognized by German Health Authorities |
| Specification | Detail |
|---|---|
| Specimen type | FFPE tissue; block preferred, slides accepted |
| Standard DNA input | 100 ng (Qubit) |
| Slide requirements (standard) | 5 sections at 4 Āµm + 1 H&E |
| Slide requirements (older blocks) | Up to 10 sections at 8 Āµm |
| Tumor cellularity | No fixed threshold; 10ā20% advisable; macrodissection performed on all samples |
| Fixation | 10% neutral buffered formalin (NBF); 24ā72 hours (24ā48 hours preferred for smaller specimens) |
| Block age | Less than 10 years preferred; younger samples preferred |
| Shipping (FFPE blocks/slides) | Ambient acceptable |
| Shipping (extracted DNA) | Dry ice required; minimum concentration ā„12 ng/Āµl by Qubit |
| DNA extraction | Performed at Discovery Life Sciences Kassel facility (preferred); extracted DNA accepted with concentration requirements above |
| Variant class | Sensitivity | Accuracy |
|---|---|---|
| SNVs / Indels | 98.1% for OncoSpan FFPE | Pearson r(expected vs observed VAF) 0.989 and mean VAF error (RPD) 9.6% for OncoSpan FFPE (100 ng) |
| 100% for for Quantitative Multiplex FFPE (100 ng) | Quantitative Multiplex VAF Accuracy – not available for FFPE sample |
| Parameter | Value |
|---|---|
| SNV LOD | 5% VAF reliably detected |
| Standard DNA input | 100 ng (Qubit) |
| Tumor cellularity threshold | No fixed threshold; 10ā20% advisable |
| Metric | Median | Mean |
|---|---|---|
| On-target coverage | 1,008.8x | 958.5x |
| On-target rate | 73.5% | 69.6% |
| Alignment rate | 98.4% | 97.8% |
| Parameter | Status |
|---|---|
| Intra-run precision (SNV/indel) | Validated against OncoSpan FFPE |
| Replicate concordance (SNV/indel) | Concordant across 100 ng replicates |
Concordance against orthogonal reference methods (NGS, dPCR, FISH for CNVs). Pearson r 98.65 at 100 ng input on OncoSpan FFPE HD832, with all expected variants detected.
LuminosĀ® Comprehensive enables rapid genomic stratification of patients at the point of enrollment ā including exclusion of patients eligible for standard-of-care therapies based on EGFR, HER2, KRAS, BRAF, and other established biomarkers. Delivered in 7 to 10 days from our in-house Kassel facility.
For sponsors developing next-generation TKIs and small molecule inhibitors, the panelās coverage of kinase pathways including PIK3CA, mTOR, and CDK pathway components, DNA damage pathways (MLH1, RAD51, TP53) , and synthetic lethal targets (BRCA1/2, ATM) supports exploratory biomarker endpoints alongside primary enrollment criteria.
IVDR-compliant status and in-house deployment under Health Institution status positions LuminosĀ® Comprehensive as a viable bridging solution for companion diagnostic development programs operating in the EU, without the performance study requirements associated with many alternative approaches.
In-house genomic testing at our Kassel, Germany facility addresses data sovereignty requirements and eliminates cross-border regulatory exposure for EU-based clinical trials.
LuminosĀ® sits within a broader Discovery Life Sciences portfolio spanning proteomics, molecular pathology, clinical flow cytometry, and biospecimen procurement, enabling single-partner workflows from sample collection to data delivery.
IVDR-compliant laboratory-developed tests deployed under Health Institution status, one of the few providers in Europe able to offer this combination for prospective clinical trial use.
Built for EU regulatory requirements and commercially available to any sponsor with EU trial sites, regardless of company headquarters. Supporting pharma sponsors and CROs across EU and US markets.
